Precision Exercise Therapeutics (PET-pilot)

Individual Responses in Insulin Sensitivity to Different Exercise Modalities in Persons With Overweight: a Randomized Cross-over Pilot Study

The aim of this randomized cross-over study is to collect information for the design of a precision exercise therapy cohort that will predict what modality of physical activity a physically inactive individual with overweight should perform to increase insulin sensitivity given their unique biology, environment, and context.

Study Overview

• Status: Completed
• Conditions: Healthy; Overweight
• Intervention / Treatment: Other: Continuous aerobic exercise; Other: High intensity interval training; Other: Resistance training

Detailed Description

This pilot study is needed prior to launching precision therapeutics programs, with the purpose to decrease the risk of research waste, increase the reliability of the experimental tests and estimate adequate sample size.

25 participants will be recruited to undergo three sets of experiments. An experiment consists of one exercise bout followed by an assessment of whole-body insulin sensitivity (measured from a oral glucose tolerance test) 1 and 2 days following the completion of the exercise bout yielding 19 study days of 3 hours each across 7 weeks, including the baseline measurement. The exercise modalities include 1) continuous aerobic exercise, 2) high intensity exercise and 3) resistance exercise training. A set consists of test-retest of the same experiment.

The objectives of this pilot study are

1. to assess the longevity of the increased whole-body insulin sensitivity in the days following different exercise modalities
2. To estimate the intra-individual differences of different exercise modalities on whole-body insulin sensitivity the days following the last exercise bout
3. To assess the fidelity of the test- and exercise protocols

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Østerbro
    • Copenhagen, Østerbro, Denmark, 2100
      • Center for Aktiv Sundhed - Rigshospitalet, Denmark (CFAS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• BMI>25
• Age> 40 years
• Inactivity, defined as < 1,5 hours of structured physical activity pr. week at moderate intensity and cycling < 30 minutes/5 km pr. day at moderate intensity (moderate intensity = out of breath but able to speak)

Exclusion Criteria:

• • HbA1c>53 mmol/mol

  • Uncontrolled hypertension
  • Uncontrolled hyperlipidemia,
  • Known hyperthyroid disease
  • Endocrine disorders causing obesity
  • Known autoimmune disease
  • Unstable cardiovascular disease
  • Glucose lowering medications except for low dose metformin (=<1000 mg/day)
  • Current treatment with anti-inflammatory medication, unless pain killers without prescription
  • No participation in other research intervention studies
  • Pregnancy/considering pregnancy within the study period
  • Conditions countering exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous aerobic exercise; The participants will complete a 10-min warm up, followed by 40 min of continuous aerobic exercise at an individualized intensity at 64-76% of the maximal heart rate HRmax on a bicycle ergometer/walking.	Other: Continuous aerobic exercise; The "Continuous aerobic exercise" session will be performed in total two times, as it will be repeated in sets on consecutive weeks (e.g. Two Tuesdays in a row) with a 1-week wash-out period. The " Continuous aerobic exercise" intervention is matched to the other arms on the time spend for each bout equating a total of 50 minutes of exercise per session. An oral glucose tolerance test will be performed 24 hours and 48 hours after the exercise bout.
Experimental: High intensity interval training; The training consists of 10 minutes of warm up followed by 25 minutes of high intensity interval training (5 bouts of 4 min at >85% HRmax interspaced by 4 minutes of low intensity training) and finally a 4 min cool-down.	Other: High intensity interval training; The "High intensity interval training" session will be performed in total two times, as it will be repeated in sets on consecutive weeks (e.g. Two Tuesdays in a row) with a 1-week wash-out period. The "High intensity interval training" intervention is matched to the other arms on the time spend for each bout equating a total of 50 minutes of exercise per session. An oral glucose tolerance test will be performed 24 hours and 48 hours after the exercise bout.
Experimental: Resistance training; The participants will complete moderate intensity whole-body resistance training. This will consist of 4 sets with 4 exercises (leg press, chest press, back row, leg extension in appropriate machines) with a brief warm-up prior to each exercise. Each set will be interspersed by 2-min breaks. Each set (including breaks) will thus equate to 2.5 min. Intensity will be set a 12-repetition max (RM, i.e., can repeated no more than 12 times) or 10 repetitions with 1-2 repetitions in reserve (i.e., 10 repetitions where failure would occur within 1-2 more repetitions).	Other: Resistance training; The "Resistance training" session will be performed in total two times, as it will be repeated in sets on consecutive weeks (e.g. Two Tuesdays in a row) with a 1-week wash-out period. The "Resistance training" intervention is matched to the other arms on the time spend for each bout equating a total of 50 minutes of exercise per session. An oral glucose tolerance test will be performed 24 hours and 48 hours after the exercise bout.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test	Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from baseline to 24 hours following the exercise bout	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test	Difference between exercise modalities in the change in whole-body insulin sensitivity (Oral glucose insulin sensitivity index) from baseline to 24 hours following the exercise bout	6 weeks
48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test	Difference between exercise modalities in the change in whole-body insulin sensitivity (Oral glucose sensitivity index) from baseline to 48 hours following the exercise bout	6 weeks
48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test	Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from baseline to 48 hours following the exercise bout	6 weeks
24 to 48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test	Difference between exercise modalities in the change in whole-body insulin sensitivity (Oral glucose sensitivity index) from 24 hours to 48 hours following the exercise bout	6 weeks
24 to 48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test	Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from 24 hours to 48 hours following the exercise bout	6 weeks
Feasibility of the test and training protocols	Feasibility will be assessed using a qualitative questionnaires. Subject domains include e.g. participant satisfaction with 1) time spend on test- and training, 2) the recruitment process, 3) communication regarding participation and 4) the written information about participation, 5) acceptability of the tests.	6 weeks
Variation in insulin sensitivity (Oral glucose sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test	The typical difference between a pair of replicate measurements in whole-body insulin sensitivity (Oral glucose sensitivity index) in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in whole-body insulin sensitivity (Oral glucose sensitivity index) in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).	6 weeks
Variation in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test	The typical difference between a pair of replicate measurements in whole-body insulin sensitivity (Matsuda index) in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in whole-body insulin sensitivity (Matsuda index) in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).	6 weeks
Variation in fasting and postprandial glucose	The typical difference between a pair of replicate measurements in fasting and post-prandial (derived from an OGTT) plasma glucose in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in fasting and post-prandial (derived from an OGTT) plasma glucose in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).	6 weeks
Variation in fasting and postprandial insulin	The typical difference between a pair of replicate measurements in fasting and post-prandial (derived from an OGTT) plasma insulin in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in fasting and post-prandial (derived from an OGTT) plasma insulin in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).	6 weeks
Variation in fasting and postprandial plasma C-peptide	The typical difference between a pair of replicate measurements in fasting and post-prandial (derived from an OGTT) plasma C-peptide in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in fasting and post-prandial (derived from an OGTT) plasma C-peptide in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).	6 weeks
Variation in gastric emptying	The typical difference between a pair of replicate measurements in post-prandial (from an OGTT) gastric empyting, measured by paracetamol, in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in post-prandial (from an OGTT) gastric empyting, measured by paracetamol, in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).	6 weeks
Assessment of free living physical activity	The typical difference between a pair of replicate measurements in free living physical activity (measured by accelerometers) in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in free living physical activity (measured by accelerometers) in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).	6 weeks
Assessment of continuous glucose	The typical difference between a pair of replicate measurements in continuous glucose (measured by continuous glucose monitors) in response to different exercise modalities following the previous exercise bout (intra-individual variation) and inter-individual response variability in continuous glucose (measured by continuous glucose monitors) in response to different exercise modalities following the previous exercise bout (inter-individual variation).	6 weeks
Assessment of psychosocial stress	The typical difference between a pair of replicate measurements in psychosocial stress (measured by questionnaires) in response to different exercise modalities following the previous exercise bout (intra-individual variation) and inter-individual response variability in psychosocial stress (measured by questionnaires) in response to different exercise modalities following the previous exercise bout (inter-individual variation).	6 weeks

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Mathias Ried-Larsen, Ph D, Center For Physical Activity Research, Rigshospitalet

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: H-22040452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If the data can be fully anonymized the data can be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No